Customed Recalls Premium Laparotomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Premium Laparotomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile surgical packs) where injury has not yet been reported, fitting the High severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling Premium Laparotomy Packs, which are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves 51 lots and 11,070 units of the product, identified by product code 900-1296.
The recall was initiated because Customed determined that there is a possibility that packaging integrity may be compromised on different catalog numbers. This potential defect could result in an injury to the patient due to product contamination or loss of sterility condition.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Consumers and healthcare facilities should stop using the affected lots and contact Customed, Inc. for instructions on return or replacement.
The recalled product
- Product
- PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PR
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product code 900-1296
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 233 products in this recall →Related recalls
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